Actively Recruiting
Randomized Phase III Trial Evaluating Durvalumab Versus Observation After Surgery in Early-Stage Non-Small Cell Lung Cancer INSIGHT
Led by National Cancer Institute (NCI) · Updated on 2026-06-03
306
Participants Needed
243
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating durvalumab, an immunotherapy drug, compared to standard patient observation after surgery in patients with early-stage non-small cell lung cancer who have no remaining cancer cells. The trial aims to determine if durvalumab can improve disease-free survival and overall outcomes compared to the usual approach of monitoring without additional treatment. This is a phase III randomized trial focusing on patients with stage II-IIIB non-small cell lung cancer who achieved a complete response after neoadjuvant chemo-immunotherapy. Participants are randomly assigned to one of two groups. One group receives durvalumab intravenously every 28 days for up to 12 cycles, pending no disease progression or unacceptable side effects. The other group undergoes active surveillance through regular follow-up without additional treatment for 12 months. Both groups have scheduled computed tomography scans and blood sample collections throughout the trial. Patients are followed annually for up to 10 years after treatment completion. During the study, participants undergo various assessments including CT scans, blood tests, and patient-reported quality of life questionnaires. Researchers monitor disease recurrence, new lung cancers, survival, and treatment side effects over a 10-year period. Quality of life and symptom evaluations related to skin and nerve sensations are also compared between the groups. This extensive follow-up helps evaluate the long-term effects and safety of durvalumab versus observation.
CONDITIONS
Brief Title
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed stage II to IIIB non-small cell lung cancer (excluding clinical N3 disease)
- Complete surgical removal (R0 resection) of lung cancer within 84 days prior to randomization (lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy only)
- Pathologic complete response with no viable tumor in resected specimen or lymph nodes
- Known PD-L1 status
- No known EGFR mutations or ALK gene fusions
- At least two cycles of neoadjuvant platinum-based chemotherapy combined with anti-PD-1 or anti-PD-L1 therapy
- No concurrent non-protocol chemotherapy, immunotherapy, biologic or hormonal therapy for lung cancer
- No systemic therapy within 28 days prior to randomization
- No post-operative radiation therapy for lung cancer
- No unresolved severe toxicities from prior anticancer therapy except alopecia and vitiligo
- Body weight greater than 30 kg
- Zubrod performance status 0 to 2
- Complete medical history and physical exam within 28 days prior to randomization
- Specific laboratory values within defined limits (hemoglobin, neutrophils, platelets, bilirubin, liver enzymes, creatinine clearance)
- Fully recovered from surgery effects
- If HIV positive, on effective anti-retroviral therapy with undetectable viral load within 6 months
- If hepatitis B positive, undetectable viral load while on suppressive therapy within 6 months
- If hepatitis C history, treated and cured or undetectable viral load if currently treated
- No organ transplant history
- No prior or concurrent malignancy interfering with safety or efficacy assessments
- No medical contraindications to immunotherapy including certain autoimmune diseases or pneumonitis
- Not pregnant or nursing and agree to use effective contraception during and after treatment
- No live or live attenuated vaccines within 28 days prior to randomization
- Willing to participate in specimen banking and patient-reported outcome studies
- Able to give informed consent or have a legally authorized representative consent
You will not qualify if you...
- Clinical N3 stage disease
- Wedge resection surgery
- Known EGFR mutations or ALK gene fusions
- Planning to receive concurrent non-protocol chemotherapy, immunotherapy, biologic or hormonal therapy
- Received systemic therapy within 28 days prior to randomization
- Received post-operative radiation therapy for lung cancer
- Unresolved toxicity of grade 2 or higher from previous anticancer therapy except alopecia and vitiligo
- Known medical contraindications to immunotherapy such as recent severe autoimmune disease or pneumonitis requiring steroids
- Pregnant or nursing
- Received live or live attenuated vaccines within 28 days prior to randomization
- History of organ transplant
- Prior or concurrent malignancy that may interfere with study assessments
- Unable to provide informed consent or no legally authorized representative available
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